(5) Papers that are submitted electronically to the Office must be formatted and transmitted in compliance with the Office’s electronic filing system requirements.

*****

(e) Electronic documents that are to become part of the permanent United States Patent and Trademark Office records in the file of a patent application or reexamination or supplemental examination proceeding.

(1) The following documents may be submitted to the Office on a compact disc in compliance with this paragraph:

(iii) Any individual table (see § 1.58 ) if the table is more than 50 pages in length, or if the total number of pages of all of the tables in an application exceeds 100 pages in length, where a table page is a page printed on paper in conformance with paragraph (b) of this section and § 1.58(c).

(2) A compact disc as used in this part means a Compact Disc-Read Only Memory (CD-ROM) or a Compact Disc-Recordable (CD-R) in compliance with this paragraph. A CD-ROM is a "read-only" medium on which the data is pressed into the disc so that it cannot be changed or erased. A CD-R is a "write once" medium on which once the data is recorded, it is permanent and cannot be changed or erased.

(3)

(i) Each compact disc must conform to the International Organization for Standardization (ISO) 9660 standard, and the contents of each compact disc must be in compliance with the American Standard Code for Information Interchange (ASCII).

(ii) Each compact disc must be enclosed in a hard compact disc case within an unsealed padded and protective mailing envelope and accompanied by a transmittal letter on paper in accordance with paragraph (a) of this section. The transmittal letter must list for each compact disc the machine format (e.g., IBM-PC, Macintosh), the operating system compatibility (e.g., MS-DOS, MS-Windows, Macintosh, Unix), a list of files contained on the compact disc including their names, sizes in bytes, and dates of creation, plus any other special information that is necessary to identify, maintain, and interpret (e.g., tables in landscape orientation should be identified as landscape orientation or be identified when inquired about) the information on the compact disc. Compact discs submitted to the Office will not be returned to the applicant.

(4) Any compact disc must be submitted in duplicate unless it contains only the "Sequence Listing" in computer readable form required by § 1.821(e). The compact disc and duplicate copy must be labeled "Copy 1" and "Copy 2," respectively. The transmittal letter which accompanies the compact disc must include a statement that the two compact discs are identical. In the event that the two compact discs are not identical, the Office will use the compact disc labeled "Copy 1" for further processing. Any amendment to the information on a compact disc must be by way of a replacement compact disc in compliance with this paragraph containing the substitute information, and must be accompanied by a statement that the replacement compact disc contains no new matter. The compact disc and copy must be labeled "COPY 1 REPLACEMENT MM/DD/YYYY" (with the month, day and year of creation indicated), and "COPY 2 REPLACEMENT MM/DD/YYYY," respectively.

(5) The specification must contain an incorporation-by-reference of the material on the compact disc in a separate paragraph (§ 1.77(b)(5) ), identifying each compact disc by the names of the files contained on each of the compact discs, their date of creation and their sizes in bytes. The Office may require applicant to amend the specification to include in the paper portion any part of the specification previously submitted on compact disc.

(6) A compact disc must also be labeled with the following information:

(i) The name of each inventor (if known);

(ii) Title of the invention;

(iii) The docket number, or application number if known, used by the person filing the application to identify the application;

(iv) A creation date of the compact disc.

(v) If multiple compact discs are submitted, the label shall indicate their order (e.g. "1 of X"); and

(vi) An indication that the disc is "Copy 1" or "Copy 2" of the submission. See paragraph (b)(4) of this section.

(7) If a file is unreadable on both copies of the disc, the unreadable file will be treated as not having been submitted. A file is unreadable if, for example, it is of a format that does not comply with the requirements of paragraph (e)(3) of this section, it is corrupted by a computer virus, or it is written onto a defective compact disc.

(f)

(1) Any sequence listing in an electronic medium in compliance with §§ 1.52(e) and 1.821(c) or (e), and any computer program listing filed in an electronic medium in compliance with §§ 1.52(e) and 1.96, will be excluded when determining the application size fee required by § 1.16(s) or § 1.492(j). For purposes of determining the application size fee required by § 1.16(s) or § 1.492(j), for an application the specification and drawings of which, excluding any sequence listing in compliance with § 1.821(c) or (e), and any computer program listing filed in an electronic medium in compliance with §§ 1.52(e) and 1.96, are submitted in whole or in part on an electronic medium other than the Office electronic filing system, each three kilobytes of content submitted on an electronic medium shall be counted as a sheet of paper.

(2) Except as otherwise provided in this paragraph, the paper size equivalent of the specification and drawings of an application submitted via the Office electronic filing system will be considered to be the number of sheets of paper present in the specification and drawings of the application when entered into the Office file wrapper after being rendered by the Office electronic filing system for purposes of computing the application size fee required by § 1.16(s). Any sequence listing in compliance with § 1.821(c) or (e), and any computer program listing in compliance with § 1.96, submitted via the Office electronic filing system will be excluded when determining the application size fee required by § 1.16(s) if the listing is submitted in ACSII text as part of an associated file.

37 C.F.R. 1.77 Arrangement of application elements.

(a) The elements of the application, if applicable, should appear in the following order:

(1) Title of the invention, which may be accompanied by an introductory portion stating the name, citizenship, and residence of the applicant (unless included in the application data sheet).

(2) Cross-reference to related applications.

(3) Statement regarding federally sponsored research or development.

(4) The names of the parties to a joint research agreement.

(5) Reference to a "Sequence Listing," a table, or a computer program listing appendix submitted on a compact disc and an incorporation-by-reference of the material on the compact disc (see § 1.52(e)(5) ). The total number of compact discs including duplicates and the files on each compact disc shall be specified.

(6) Statement regarding prior disclosures by the inventor or a joint inventor.

(c) The text of the specification sections defined in paragraphs (b)(1) through (b)(12) of this section, if applicable, should be preceded by a section heading in uppercase and without underlining or bold type.

In view of lengthy data listings being submitted as part of the disclosure in some patent applications, the Office established procedures for the presentation of large tables (37 CFR 1.58 ), computer program listings (37 CFR 1.96 ) and biotechnology sequence listings (37 CFR 1.821(c) ) in electronic form. Such listings are often several hundred pages or more in length. By filing and publishing such data listings in electronic form, substantial cost savings can result to the applicants, the public, and the U.S. Patent and Trademark Office.

The following document types may be submitted as ASCII text files with a ".txt" extension via EFS-Web or as compact discs in compliance with 37 CFR 1.52(e) and 1.821 et seq. provided the specification contains a statement in a separate paragraph that incorporates by reference the material in the ASCII text file identifying the name of the ASCII text file, the date of creation, and the size of the ASCII text file in bytes:

(3) Any individual table (see 37 CFR 1.58 ) if the table is more than 50 pages in length, or if the total number of pages of all of the tables in an application exceeds 100 pages in length, wherein a table page is a page printed on paper in conformance with 37 CFR 1.52(b) and 1.58(c).

I. TEXT FILES SUBMITTED VIA EFS-WEB

The requirements of 37 CFR 1.52(e)(3)-(6) for documents submitted on compact disc are not applicable to computer program listings, sequence listings, and tables submitted as ASCII text files via EFS-Web. However, each text file must be in compliance with ASCII and have a file name with a ".txt" extension. Further, the specification must contain an incorporation-by-reference of the material in the ASCII text file in a separate paragraph identifying the name of the ASCII text file, the date of creation, and the size of the ASCII text file in bytes similar to the requirements of 37 CFR 1.52(e)(5) for compact discs. See 37 CFR 1.77(b)(5).

Form paragraphs 6.61.02 and 6.71.02 (reproduced in subsection II., below) may be used to indicate the need to add or amend an incorporation by reference statement for text files submitted via EFS-Web.

A. Information Specific to Sequence Listings

It is recommended that a sequence listing be submitted in an ASCII text file via EFS-Web rather than in a PDF file. If a sequence listing text file submitted via EFS-Web on the application filing date complies with the requirements of 37 CFR 1.824(a)(2)-(6) and (b), and applicant has not filed a sequence listing in a PDF file (or on paper) on the same day, the text file will serve as both the paper copy required by 37 CFR 1.821(c) and the computer readable form (CRF) required by 37 CFR 1.821(e). Thus, the following are not required and should not be submitted: (1) a second copy of the sequence listing in a PDF file; (2) a statement under 37 CFR 1.821(f) (indicating that the paper copy and CRF copy of the sequence listing are identical); and (3) a request to use a compliant computer readable "Sequence Listing" that is already on file for another application pursuant to 37 CFR 1.821(e). If such a request is filed, the USPTO will not carry out the request but will use the sequence listing submitted in an ASCII text file with the application via EFS-Web. See MPEP § 2422.05. Checker software that may be used to check a sequence listing for compliance with the requirements of 37 CFR 1.824 is available on the USPTO website at www.uspto.gov/patents-getting-started/patent-basics/ types-patent-applications/utility-patent/checker-version-446.

If a user submits a sequence listing (under 37 CFR 1.821(c) and (e) ) as an ASCII text file via EFS-Web in response to a requirement under 37 CFR 1.821(g) or (h), the sequence listing text file must be accompanied by a statement that the submission does not include any new matter which goes beyond the disclosure of the application as filed. In addition, if a user submits an amendment to, or a replacement of, a sequence listing (under 37 CFR 1.821(c) and (e) ) as an ASCII text file via EFS-Web, the sequence listing text file must be accompanied by: (1) a statement that the submission does not include any new matter; and (2) a statement that indicates support for the amendment in the application, as filed. See 37 CFR 1.825.

Submission of the sequence listing in a PDF file on the application filing date is not recommended. Applicant must still provide the CRF required by 37 CFR 1.821(e), and the sequence listing in the PDF file will not be excluded when determining the application size fee. The USPTO prefers the submission of a sequence listing in an ASCII text file via EFS-Web on the application filing date because as stated above, if applicant has not filed a second copy of the sequence listing in a PDF file (or on paper) on the same day, the text file will serve as both the paper copy required by 37 CFR 1.821(c) and the CRF required by 37 CFR 1.821(e). Any sequence listing submitted in PDF format (or on paper) on the application filing date is treated as the paper copy required by 37 CFR 1.821(c). If applicant submits both a sequence listing in a PDF file and an ASCII text file via EFS-Web on the application filing date, a statement that the sequence listing content of the PDF copy and the ASCII text file copy are identical is required. In situations where applicant files the sequence listing in PDF format and requests the use of the CRF of another application under 37 CFR 1.821(e), applicant must submit a letter and request in compliance with 37 CFR 1.821(e) and a statement that the PDF copy filed in the new application is identical to the CRF filed in the other application. See also MPEP § 2422.05.

B. Application Size Fee

Any sequence listing submitted as an ASCII text file via EFS-Web that is otherwise in compliance with 37 CFR 1.52(e) and 1.824(a)(2)-(6) and (b), and any computer program listing submitted as an ASCII text file via EFS-Web that is otherwise in compliance with 37 CFR 1.52(e) and 1.96, will be excluded when determining the application size fee required by 37 CFR 1.16(s) or 1.492(j) as per 37 CFR 1.52(f)(1).

Regarding a table submitted as an ASCII text file via EFS-Web that is part of the specification or drawings, each three kilobytes of content submitted will be counted as a sheet of paper for purposes of determining the application size fee required by 37 CFR 1.16(s) or 1.492(j). Each table should be submitted as a separate text file. Further, the file name for each table should indicate which table is contained therein.

C. Size Limit for Text Files

One hundred (100) megabytes is the size limit for sequence listing text files submitted via EFS-Web; for all other text file types, 25 megabytes is the size limit. If a user wishes to submit an electronic copy of a file that exceeds these size limits, it is recommended that the electronic copy be submitted on compact disc via Priority Mail Express® from the USPS in accordance with 37 CFR 1.10, or hand delivery, on the date of the corresponding EFS-Web filing in accordance with 37 CFR 1.52(e) if the user wishes the electronic copy to be considered to be part of the application as filed.

II. Submissions On Compact Disc

A compact disc submitted under 37 CFR 1.52(e) must either be a CD-ROM or a CD-R. A CD-ROM is made by a process of pressing the disc from a master template; the data cannot be erased or rewritten. A CD-R is a compact disc that has a recording medium only capable of writing once. CD-RW type media which are erasable and rewriteable are not acceptable. Limiting the media types to CD-ROM and CD-R media will ensure the longevity and integrity of the data submitted. The files stored on the compact disc must contain only ASCII characters. No non-ASCII characters or proprietary file formats are permitted. A text viewer is recommended for viewing ASCII files. While virtually any word processor may be used to view an ASCII file, care must be taken since a word processor will often not distinguish ASCII and non-ASCII files when displayed. For example, a word processor normally does not display hidden proprietary non-ASCII characters used for formatting when viewing a non-ASCII word processor file.

Compact disc(s) filed on the date that the application was accorded a filing date are to be treated as part of the originally filed disclosure even if the requisite "incorporation by reference" statement (see 37 CFR 1.77(b)(5) ) is omitted. Similarly, if a preliminary amendment accompanies the application when it is filed in the Office and the preliminary amendment includes compact disc(s), the compact disc(s) will be treated as part of the original disclosure. The compact disc(s) is considered part of the original disclosure by virtue of its inclusion with the application on the date the application is accorded a filing date. The incorporation by reference statement of the material on the compact disc is required to be part of the specification so it is clear to the Office, the printer, and the public that the application as originally filed includes material on compact disc. The examiner should require applicant(s) to insert this statement if it is omitted or the examiner may insert the statement by examiner’s amendment at the time of allowance.

37 CFR 1.52(e)(3)(ii) requires that each compact disc must be enclosed in a hard compact disc case within an unsealed padded and protective mailing envelope and accompanied by a transmittal letter on paper in accordance with 37 CFR 1.52(a). The transmittal letter must list for each compact disc the machine format (e.g., IBM-PC, Macintosh), the operating system compatibility (e.g., MS-DOS, MS-Windows, Macintosh, Unix), a list of files contained on the compact disc including their names, sizes in bytes, and dates of creation, plus any other special information that is necessary to identify, maintain, and interpret the information on the compact disc. Compact discs submitted to the Office will not be returned to the applicant.

All compact discs submitted under 37 CFR 1.52(e) must be submitted in duplicate labeled as "copy 1" and "copy 2" respectively. If more than one compact disc is required to hold all of the information, each compact disc must be submitted in duplicate to form two sets of discs: one set labeled "copy 1" and a second set labeled "copy 2." Both disc copies should initially be routed to the Office of Patent Application Processing (OPAP). The compact discs will be checked by OPAP for viruses, readability, the presence of non-ASCII files, and compliance with the file and disc labeling requirements. OPAP will retain one copy of the discs and place the other copy in an artifact folder associated with the Image File Wrapper. In the event that there is not a complete set of files on both copies of the originally filed discs, OPAP will retain the originally filed discs and send a notice to the applicant to submit an additional complete copy. For provisional applications, OPAP will provide applicant notification and, where appropriate, require correction for virus infected compact discs, unreadable compact discs (or unreadable files thereon), and missing duplicate discs.

An amendment to the material on a compact disc must be done by submitting a replacement compact disc with the amended file(s) or by filing the material as text file(s) via EFS-Web. The amendment should include a corresponding amendment to the description of the incorporation by reference portion of the specification. A replacement compact disc containing the amended files must contain all of the files of the original compact disc that were not amended. This will insure that the Office, printer, and public can quickly access all of the current files in an application or patent by referencing only the latest electronic version of the ASCII file.

The following form paragraphs may be used to notify applicant of corrections needed with respect to compact disc submissions.

This application is objected to under 37 CFR 1.52(e)(4) because it does not contain a statement in the transmittal letter that the two compact discs are identical. Correction is required.

¶ 6.60.02 CD-ROM/CD-R Requirements (No Listing in Transmittal Letter)

This application is objected to because it contains a data file on CD-ROM/CD-R, however, the transmittal letter does not list for each compact disc, the machine format, the operating system compatibility, a list of files contained on the compact disc including their names, sizes in bytes, and dates of creation, plus any other special information that is necessary to identify, maintain, and interpret the information on the compact disc as required by 37 CFR 1.52(e)(3). A statement listing the required information is required.

Portions of this application are contained on compact disc(s). When portions of an application are contained on a compact disc, the paper portion of the specification must identify the compact disc(s) and list the files including name, file size, and creation date on each of the compact discs. See 37 CFR 1.52(e). Compact disc labeled[1] is not identified in the paper portion of the specification with a listing of all of the files contained on the disc. Applicant is required to amend the specification to identify each disc and the files contained on each disc including the file name, file size, and file creation date.

Examiner Note:

This application contains compact disc(s) or text file(s) submitted via EFS-Web as part of the originally filed subject matter, but does not contain an incorporation by reference statement for the compact discs or text files. See 37 CFR 1.77(b)(5) and MPEP § 502.05. Applicant(s) are required to insert in the specification an appropriate incorporation-by-reference statement.

¶ 6.62 Data File on CD-ROM/CD-R Not in ASCII File Format

This application contains a data file on CD-ROM/CD-R that is not in an ASCII file format. See 37 CFR 1.52(e). File [1] is not in an ASCII format. Applicant is required to resubmit file(s) in ASCII format. No new matter may be introduced in presenting the file(s) in ASCII format.

Examiner Note:

1. This form paragraph must be used to indicate whenever a data file (table, computer program listing or Sequence Listing) is submitted in a non-ASCII file format. The file may be in a file format that is proprietary, e.g., a Microsoft Word, Excel or Word Perfect file format; and/or the file may contain non-ASCII characters.

2. In bracket 1, insert the name of the file and whether the file is a non-text proprietary file format and/or contains non-ASCII characters.

The following form paragraphs should be used to respond to amendments which include amended or substituted compact discs.

¶ 6.70.01 CD-ROM/CD-R Requirements (Amendment Does Not Include Statement that CDs are Identical)

The amendment filed [1] is objected to under 37 CFR 1.52(e)(4) because it does not contain a statement in the transmittal letter that the two compact discs are identical. Correction is required.

The amendment filed [1] contains data on compact disc(s). Compact disc labeled [2] is not identified in the transmittal letter and/or the transmittal letter does not list for each compact disc, the machine format, the operating system compatibility, a list of files contained on the compact disc including their names, sizes in bytes, and dates of creation, plus any other special information that is necessary to identify, maintain, and interpret the information on the compact disc as required by 37 CFR 1.52(e)(3). A statement listing the required information is required.

Examiner Note:

1. Use this form paragraph when the transmittal letter does not include a listing of the files and required information.

The amendment filed [1] contains data on compact disc(s). Compact disc labeled [2] is not identified in the paper portion of the specification with a listing of all of the files contained on the disc. Applicant is required to amend the specification to identify each disc and the files contained on each disc including the file name, file size, and file creation date. See 37 CFR 1.52(e).

The amendment filed [1] amends or adds compact disc(s) or text file(s) submitted via EFS-Web. Applicant is required to update or insert an appropriate incorporation-by-reference statement in the specification. See 37 CFR 1.77(b)(5) and 1.52(e)(5).

Examiner Note:

1. Use this form paragraph when a CD-ROM/CD-R or text file submitted via EFS-Web is filed with an amendment, but the required incorporation-by-reference statement is neither amended nor added to the specification.

2. In bracket 1, insert the date of the amendment.

¶ 6.72.01 CD-ROM/CD-R Requirements (CDs Not Identical)

The amendment filed [1] is objected to under 37 CFR 1.52(e)(4) because the two compact discs are not identical. Correction is required.

Examiner Note:

1. Use this form paragraph when the two compact discs are not identical.

2. See also form paragraph 6.70.01 where the transmittal letter does not include a statement that the two compact discs are identical.

The amendment filed [1] contains a data file on CD-ROM/CD-R that is not in an ASCII file format. File [2] is not in an ASCII format. Applicant is required to resubmit file(s) in ASCII format as required by 37 CFR 1.52(e)(3). No new matter may be introduced in presenting the file(s) in ASCII format.

Examiner Note:

1. This form paragraph must be used whenever a data file (table, computer program listing or Sequence Listing) is submitted in a non-ASCII file format. The file may be in a file format that is proprietary, e.g., a Microsoft Word, Excel or Word Perfect file format; and/or the file contains non-ASCII characters.

2. In bracket 1, insert the date of the amendment.

3. In bracket 2, insert the name of the file and whether the file is a non-text proprietary file format and/or contains non-ASCII characters.

¶ 6.72.03 CD-ROM/CD-R Are Not Readable

The amendment filed [1] contains a data file on CD-ROM/CD-R that is unreadable. Applicant is required to resubmit the file(s) in International Organization for Standardization (ISO) 9660 standard and American Standard Code for Information Interchange (ASCII) format as required by 37 CFR 1.52(e)(3). No new matter may be introduced in presenting the file in ISO 9660 and ASCII format.

¶ 6.72.04 CD-ROM/CD-R Contains Viruses

The amendment filed [1] is objected to because the compact disc contains at least one virus. Correction is required.

The amendment to the application filed [1] is objected to because the newly submitted compact disc(s) do not contain all of the unamended data file(s) together with the amended data file(s) that were on the CD-ROM/CD-R. Since amendments to a compact disc can only be made by providing a replacement compact disc, the replacement disc must include all of the files, both amended and unamended, to be a complete replacement.

Examiner Note:

Use this form paragraph when a replacement compact disc is submitted that fails to include all of the files on the original compact disc(s) that have not been cancelled by amendment.